Ballard* Closed Suction System 98384Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00609038983844), received between Oct 22, 2020 and Mar 19, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2026Inflation Problem; Gas/Air Leak; Infusion or Flow Problem

  IT WAS REPORTED, THE NEW IN-LINE SUCTION CATHETER (CSC) WAS ATTACHED TO THE ENDOTRACHEAL TUBE (ETT). IT WAS NOTED THAT UPON THE SECOND USE OF THE CSC IT HAD FILLED WITH AIR, THE VENTILATOR ALARMED HIGH LEAK, AND THE PATIENT DESATURATED. THE PORT WAS TURNED ON AND OFF, THE CSC WAS REMOVED AND THE DEVICE WAS REPLACED. THERE WAS NO REPORTED INJURY.

  Patient problems: Low Oxygen Saturation

  MAUDE report 24645111 ↗
• MalfunctionAug 7, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED: THE CLOSED SUCTION SYSTEM SUDDENLY POPPED OFF DURING ONGOING MECHANICAL VENTILATION; THE COUPLING DID NOT SEEM TO ATTACH AT ALL; UPON CLOSER INSPECTION OF THE PRODUCT, A TRANSPARENT OIL-LIKE LIQUID COULD BE SEEN AT THE Y-PIECE COUPLING. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 22745238 ↗
• MalfunctionApr 10, 2025Leak/Splash; Leak/Splash

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 8030647-2025-00041 FOR THE FIRST REPORT. REFER TO 8030647-2025-00042 FOR THE SECOND REPORT. IT WAS REPORTED, THE CLOSED INLINE SUCTION SYSTEM FOR VENTILATED BABIES INFLATED AFTER SUCTIONING WHICH CAUSED THE VENTILATOR TO ALARM FOR HIGH PATIENT LEAK (UP TO 100%) WITH A DISPLAYED TIDAL VOLUME OF ZERO. THE PATIENT REQUIRED HIGH FRACTION OF INSPIRED OXYGEN (FIO2) AND INTERMITTENT POSITIVE PRESSURE VENTILATION (IPPV) VIA THE NEO PUFF IN ORDER TO ACHIEVE EFFECTIVE VENTILATION. THE DEVICE WAS DISCONNECTED/RECONNECTED AND REINFLATED AND THE PATIENT'S PERIPHERAL CAPILLARY OXYGEN SATURATION (SPO2) DROPPED. THE INLINE SUCTION WAS REPLACED AND THE ISSUE RESOLVED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 21819182 ↗
• MalfunctionJan 16, 2025Loose or Intermittent Connection; Gas/Air Leak; Loose or Intermittent Connection; Gas/Air Leak

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 8030647-2025-00008 FOR THE FIRST REPORT. IT WAS REPORTED, THE CONNECTION BETWEEN THE Y PIECE AND THE SUCTION PROBE WAS TOO LOOSE/NOT FIRMLY ATTACHED; THERE WAS A DISCONNECTION/LEAK IN THE VENTILATION HOSE CIRCUIT AND THE PATIENT WAS NOT RECEIVING THE RIGHT BREATHING. THERE WAS NO REPORTED INJURY.

  Patient problems: Low Oxygen Saturation

  MAUDE report 21174833 ↗
• MalfunctionJan 16, 2025Loose or Intermittent Connection; Gas/Air Leak; Loose or Intermittent Connection; Gas/Air Leak

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO 8030647-2025-00009 FOR THE SECOND REPORT IT WAS REPORTED, THE CONNECTION BETWEEN THE Y PIECE AND THE SUCTION PROBE WAS TOO LOOSE/NOT FIRMLY ATTACHED; THERE WAS A DISCONNECTION/LEAK IN THE VENTILATION HOSE CIRCUIT AND THE PATIENT WAS NOT RECEIVING THE RIGHT BREATHING. THE DEVICE WAS REPLACED. THERE WAS NO REPORTED INJURY.

  Patient problems: Low Oxygen Saturation

  MAUDE report 21174830 ↗
• MalfunctionApr 8, 2024Material Integrity Problem; Material Integrity Problem

  PER GOOGLE TRANSLATE: IT WAS REPORTED, "THE CONNECTION TIP LOOSENED WITHOUT HAVING FORCE. THE NURSE QUICKLY IDENTIFIED THE PROBLEM AS A RISK OF DETERIORATION OF THE CHILD'S BREATHING FOLLOWING POOR VENTILATION; THE CLOSED SUCTION SYSTEM WAS CHANGED." THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED 2024MAR22 REPORTED, THE CONNECTING END SPLIT, WITHOUT USING FORCE; NO PATIENT HARM OCCURRED AS A RESULT OF THE REPORTED INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19066612 ↗
• MalfunctionJun 6, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED, "THE CHILD DESATURATED AND STARTED BRADY CARDING. IN ARRIVING AT THE CHILD, THE CAREGIVER REALIZED THAT THE TRACH-CARE WAS INFLATED AND WAS BEING VENTILATED BY THE MACHINE. HE ALSO NOTICED THAT THE CHILD DID NOT TAKE ITS VOLUMES AND HAD 100% LEAKAGE. THE CHILD THEREFORE DID NOT RECEIVE HIS VENTING PROPERLY. A COLLEAGUE QUICKLY LEFT TO LOOK FOR A NEW TRACH-CARE TO REPLACE THE DEFECTIVE ONE." PER THE REPORTER, THE DECLARATION IS ANONYMOUS, AND THE REPORTER CANNOT PROVIDE ANY FURTHER INFORMATION.

  Patient problems: Bradycardia; Hypoventilation

  MAUDE report 17075087 ↗
• MalfunctionOct 22, 2020Component Missing; Gas/Air Leak; Component Missing; Gas/Air Leak

  IT WAS REPORTED THAT A (B)(6) OLD FEMALE WEIGHING (B)(6) HAD A SUCTION CATHETER PLACED. A FEW HOURS LATER, THE VENTILATOR ALARMED FOR "LEAK." THE VENTILATOR WAS CHANGED, HOWEVER, THE PROBLEM PERSISTED. THE SUCTION CATHETER SYSTEM WOULD NOT SUCTION, AS THE BUTTON SEEMED TO BE MISSING A SPRING. THERE WAS NO INJURY TO THE PATIENT OTHER THAN RESPIRATORY DESTABILIZATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED.

  Patient problems: No Code Available

  MAUDE report 10718021 ↗